MEMFIX 042.700V5

GUDID 07630031718228

Crosshead mini-screws D1.5mm, L8mm

Institut Straumann AG

Screw endosteal dental implant, one-piece

• Primary Device ID: 07630031718228
• NIH Device Record Key: 2815fdcd-7488-4b2f-8a07-7b7fb0c453e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEMFIX
• Version Model Number: Fixation Screws
• Catalog Number: 042.700V5
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031718228 [Primary]
GS1	07630031747112 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955369

FDA Product Code

• DZL: SCREW, FIXATION, INTRAOSSEOUS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630031718228]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

On-Brand Devices [MEMFIX]

• 07630031718259: Crosshead mini-screws D1.5mm, L14mm
• 07630031718242: Crosshead mini-screws D1.5mm, L12mm
• 07630031718235: Crosshead mini-screws D1.5mm, L10mm
• 07630031718228: Crosshead mini-screws D1.5mm, L8mm